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About the role:
We are seeking a Sr. Document Control Manager to develop strategy, structure, tooling and organization around document and process control for commercial and operation functions. The ideal candidate will work closely with Production and R&D teams to support new product introduction and administrate the Arena PLM tool and BOM setups in the electronic documentation and ERP systems. The position will manage a team of documentation specialists to ensure processes are in compliance under the ISO quality management systems.
What you will be doing:
- Lead and manage the document control team that processes document changes (ECO), engineering change requests (ECR) and record retention policies.
- Develop and maintain the administration and approval matrix of all engineering changes; support QA in managing the QMS flow for Deviations, NCR, CAPA, etc.
- Manage documentation archive of product design history files, validation plans and reports, and production records. Ensure all document control processes and retention of records are in compliance with applicable ISO and QMS standards.
- Collaborate with Quality Assurance team to create training contents for document related quality management processes.
- Oversee part number creation and revision change of items. Work with Productivity Engineering team in the maintenance of item templates to ensure item functionality in the ERP system.
- Lead projects associated with global process harmonization to ensure consistent document control practice at different sites.
- Create department KPIs and monitor team performance.
- Ensure proper document and record management resourcing are established to support the growth of the company.
- Perform other quality related duties as assigned.
Minimum Requirements:
- 7+ Years as a Document Control Manager or equivalent
- Hands-on experience in ISO and quality management systems implementation and certification
- Hands-on experience with Arena PLM system selection and implementation
- Strong written and verbal communication skills and process
- Experienced with internal, external auditing programs with great attention to detail
- Self-Starting, detail oriented, quick learner, strategic, creative, and analytical
Preferred Skills and Experience:
- Degree in Sciences
- 5+ Years working in Life Sciences or Bio-Pharmaceutical industries
- Arena PLM/ERP integration experience
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Below is the salary range for this full time position. The actual base pay will depend on several factors unique to each candidate, including one’s skills, qualifications, and experience. At 10x, the base salary is also just one component of the Company’s total compensation package.This role is also eligible for 10x’s annual bonus program, equity grants, and comprehensive health and retirement benefit programs. Your 10x recruiter can share more about the specific salary range during the hiring process.
About 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation,or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.